`
`
`
`SUPPLEMENT APPROVAL
`FULFILLMENT OF POSTMARKETING
`REQUIREMENT
`
`
`American Regent, Inc.
`Attention: Elizabeth Ernst
`Global Executive Director of Regulatory Affairs
`5 Ramsey Road
`Shirley, NY 11967
`
`
`Dear Ms. Ernst:
`
`Please refer to your supplemental new drug application (sNDA) dated and received
`January 29, 2021, and your amendments, submitted under section 505(b) of the
`Federal Food, Drug, and Cosmetic Act (FDCA) for Injectafer (ferric carboxymaltose
`injection) 50 mg/mL.
`
`We also refer to your submission dated January 29, 2021, containing the final report for
`postmarketing requirement 2064-2 listed in the July 25, 2013, approval letter.
`
`This Prior Approval supplemental new drug application provides for the use of Injectafer
`(ferric carboxymaltose injection) as an iron replacement product indicated for the
`treatment of iron deficiency anemia in pediatric patients 1 year of age and older, who
`have either intolerance to oral iron or an unsatisfactory response to oral iron.
`
`APPROVAL & LABELING
`
`We have completed our review of this application, as amended. It is approved, effective
`on the date of this letter, for use as recommended in the enclosed agreed-upon
`labeling.
`
`CONTENT OF LABELING
`
`As soon as possible, but no later than 14 days from the date of this letter, submit the
`content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using
`the FDA automated drug registration and listing system (eLIST), as described at
`FDA.gov.1 Content of labeling must be identical to the enclosed labeling (Prescribing
`Information, Patient Package Insert), with the addition of any labeling changes in
`
`
`1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`
`Reference ID: 4891843
`
`
`
`NDA 203565/S-016
`Page 2
`
`
`pending “Changes Being Effected” (CBE) supplements, as well as annual reportable
`changes not included in the enclosed labeling.
`
`Information on submitting SPL files using eList may be found in the guidance for
`industry SPL Standard for Content of Labeling Technical Qs and As.2
`
`The SPL will be accessible from publicly available labeling repositories.
`Also within 14 days, amend all pending supplemental applications that include labeling
`changes for this NDA, including CBE supplements for which FDA has not yet issued an
`action letter, with the content of labeling [21 CFR 314.50(l)(1)(i)] in Microsoft Word
`format, that includes the changes approved in this supplemental application, as well as
`annual reportable changes. To facilitate review of your submission(s), provide a
`highlighted or marked-up copy that shows all changes, as well as a clean Microsoft
`Word version. The marked-up copy should provide appropriate annotations, including
`supplement number(s) and annual report date(s).
`
`REQUIRED PEDIATRIC ASSESSMENTS
`
`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for
`new active ingredients (which includes new salts and new fixed combinations), new
`indications, new dosage forms, new dosing regimens, or new routes of administration
`are required to contain an assessment of the safety and effectiveness of the product for
`the claimed indication in pediatric patients unless this requirement is waived, deferred,
`or inapplicable.
`
`Because none of these criteria apply to your application, you are exempt from this
`requirement.
`
`FULFILLMENT OF POSTMARKETING REQUIREMENT(S)/COMMITMENT(S)
`
`We have reviewed your submission containing the final study report for the following
`postmarketing requirment and conclude that the below requirement was fulfilled.
`
`
`2064-2
`
`Determine the safety and efficacy of Injectafer (ferric
`carboxymaltose injection) in pediatric patients aged 1 to <17 years
`with iron deficiency anemia by conducting a randomized, active-
`controlled clinical trial.
`
`Final Protocol Submission: 01/2017
`Study Completion: 01/2020
`Final Report Submission: 01/2021
`
`
`
`
`
`
`2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
`Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
`
`U.S. Food and Drug Administration
`Silver Spring, MD 20993
`www.fda.gov
`
`Reference ID: 4891843
`
`
`
`NDA 203565/S-016
`Page 3
`
`
`This completes all of your postmarketing requirements acknowledged in our
`July 25, 2013, approval letter.
`
`PROMOTIONAL MATERIALS
`
`You may request advisory comments on proposed introductory advertising and
`promotional labeling. For information about submitting promotional materials, see the
`final guidance for industry Providing Regulatory Submissions in Electronic and Non-
`Electronic Format-Promotional Labeling and Advertising Materials for Human
`Prescription Drugs.3
`
`You must submit final promotional materials and Prescribing Information, accompanied
`by a Form FDA 2253, at the time of initial dissemination or publication
`[21 CFR 314.81(b)(3)(i)]. Form FDA 2253 is available at FDA.gov.4 Information and
`Instructions for completing the form can be found at FDA.gov.5
`
`REPORTING REQUIREMENTS
`
`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
`
`If you have any questions, call Carleveva Thompson, Regulatory Project Manager, at
`301-796-1403.
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`
`Albert Deisseroth, MD, PhD
`Deputy Division Director
`Division of Nonmalignant Hematology
`Office of Cardiology, Hematology,
`Endocrinology, and Nephrology
`Center for Drug Evaluation and Research
`
`
`
`ENCLOSURE(S):
`• Content of Labeling
`o Prescribing Information
`o Patient Package Insert
`
`
`
`
`3 For the most recent version of a guidance, check the FDA guidance web page at
`https://www.fda.gov/media/128163/download.
`4 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf
`5 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf
`U.S. Food and Drug Administration
`Silver Spring, MD 20993
`www.fda.gov
`
`Reference ID: 4891843
`
`
`
`Signature Page 1 of 1
`--------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically. Following this are manifestations of any and all
`electronic signatures for this electronic record.
`--------------------------------------------------------------------------------------------
`/s/
`------------------------------------------------------------
`
`ALBERT B DEISSEROTH
`11/19/2021 02:41:46 PM
`
`Reference ID: 4891843
`
`